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Monthly Archives: February 2015

On April 17, 2012, Brazil became the first emerging country to institute a fast-track program for the accelerated examination of patent applications directed to alternative energy, transportation, energy conservation, waste management and agriculture (a full list of qualifying technologies can be found here). This program became known as the “green” patent pilot program. The goal of the program has been to conduct examination of applications covering these technologies in two years or less. Generally, the average prosecution time in Brazil is over ten years.

In order to participate in the program, an applicant must comply with the following:

the application (a patent application or utility mode) must not have undergone technical examination;

the application must contain no more than 15 total claims (three of which are independent);

submission of the form specific to the pilot program;

request examination (if not already requested); and

request publication (if the application has not already been published).

According to the information available in the Brazilian PTO web site, since the beginning of the program until the last available update (February 3, 2015), a total of 41 patents have been granted, 46 applications have been rejected, 99 applications have suffered an unfavorable opinion and 53 applications have received Office Actions. In fact, at the National Institute of Industrial Property’s (INPI) website, it is possible to follow the progress applications in the program as well as view statistics on a number of aspects of the program (such as the number of granted, rejected or shelved applications, the number of office actions issued, etc.).

The program is currently in its third phase. As part of this final phase, the program is now accepting patent applications filed under the Patent Cooperation Treaty (PCT). The third phase of the program will end on April 16, 2015 (or if 500 new applications meeting the requirements are filed).

Applicants wishing to take advantage of this program should do so sooner rather than later as time is running out to participate in this program.

This post was written by Lisa Mueller and Roberto Rodrigues and André Venturini of Licks Attorneys.

China has the second largest seed market in the world. Annually, China uses roughly 12.5 million tons of planting seed. In 2012, the Ministry of Agriculture (MOA) estimated the seed market to be approximately RMB $104 billion (U.S. $17 billion) of which 65 percent was hybrid corn, hybrid rice, vegetable and fruit seeds.

China is in the process of revising its seed law in an effort to develop a stronger domestic seed industry. In January 2014, a revised draft seed law (Seed Law) was completed by the National People’s Congress (NPC) Agriculture and Rural Affairs Committee. In August 2014, the draft was sent to the State Council for review. It is expected that the Seed Law will be ready for reading by the Standing Committee of the NPC some time in April 2015.

The draft Seed Law is expected to improve the level of legal protections available for plant varieties. For example, the draft Seed Law stipulates the content, ownership and grant conditions for plant variety protection (PVP) including application, examination, grant, implementation, infringement and exceptions, the period of protection, termination and invalidation. Importantly, the draft increases the penalties for the infringement and counterfeiting (such as passing off). Moreover, the draft reflects some of the advancements of the 1991 International Convention for the Protection of New Plant Varieties Union (UPOV Convention) such as extending the period of protection to 5 years, extending the object of protection from propagation material to receiving goods, etc.

Please watch the BRIC Wall Blog for further updates regarding China’s updated Seed Law. This post was written by Lisa Mueller.

This is an update to our September 5, 2014 post reporting the unanimous decision of the Full Court of the Federal Court of Australia (Full Court) in Yvonne D’Arcy v Myriad Genetics Inc., holding that isolated DNA and RNA constitute patent eligible subject matter. On February 13, 2015, the High Court of Australia (High Court) granted Special Leave to Appeal to Ms D’Arcy.

At first instance, Justice Nicholas found Australian Patent No. 686004 (Patent) covering theBRCA1 gene valid holding that the claimed invention constituted a “manner of manufacture”. The Full Court dismissed the application to revoke the Patent. Specifically, the Full Court agreed with Justice Nicholas that the Patent was valid and dismissed the appeal. In its decision, the Full Court confirmed the test set out in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 for determining whether or not an invention constitutes a manner of manufacture. Specifically, according to the test, an invention is a manner of manufacture if it results in an artificial state of affairs providing a new and useful effect that is of economic significance.

Ms. D’Arcy contested Full Court’s decision arguing that isolating a gene from the human body is not a form of “manufacture”, but instead constitutes a product of nature as determined by the U.S. Supreme Court. As discussed in our September 5th post, the Full Court was highly critical of the U.S. Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc. stating:

The U.S. Supreme Court rejected the claim over isolated nucleic acids for much the same reasons as those pressed by the applicant in this case. It is difficult to reconcile that Court’s endorsement of the reasoning in Chakrabarty, with its rejection of isolated nucleic acid as eligible for patentability. With respect, the Supreme Court’s emphasis on the similarity of ‘the location and order of the nucleotides’ existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful.

The fact that the High Court is interested in hearing this case in view of the unanimous decision of the Full Court clearly indicates that the High Court believes this case warrants serious consideration. A subsequent decision adverse to Myriad could be devastating for the biotechnology industry in Australia.

Please watch the BRIC Wall for further updates on patent eligible subject matter. This post was written by Lisa Mueller.

As discussed in previous posts, at least twelve countries have issued compulsory licenses for a variety of pharmaceutical pharmaceuticals (See, Part 1 and Part 2 of our series on compulsory licensing in India). On December 19, 2014, S. Kalashnikov, the Chairman of the Committee of the State Duma for Health Protection, sent to D. Medvedev, the Prime Minister of the Russian Federation, a letter regarding compulsory licensing. Given the current geopolitical and economic situation, the State Duma Committee for Health Protection is considering implementing compulsory licensing for certain high-tech and biotech medicinal products for the treatment of orphan diseases and disease having the greatest impact on mortality in the Russian Federation. A translation of the letter is provided below.

To: PrimeMinister of the Russian Federation

D.A. MEDVEDEV

Dear Dmitry Anatolyevich!

Currently, some countries began to actively use the mechanism of compulsory licenses for the production of generic medicines before the expiration of patent protection for the original medicinal product (India, Brazil, Indonesia, Thailand, etc.). The governments of the aforementioned countries are supported by the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Doha declaration on the public health. According to these documents, compulsory licensing mechanism is applied in the case of severe social requirements and is used for the production of medicinal products to treat common serious diseases in the country such as AIDS, hepatitis, cancer, and also in the event of an epidemy.

In the current geopolitical and economic situation, the State Duma Committee for Health Protection deems it necessary to consider the implementation of compulsory licensing mechanism for the production of some high-technological and biotechnological medicinal products for the treatment of orphan (rare) diseases and diseases that have the greatest impact on mortality in the Russian Federation.

Sincerely yours,

Chairman of the Committee

S.V. Kalashnikov

Please watch the BRIC Wall Blog for updates on compulsory licensing in the Russian Federation.